Diabetes Mellitus Type 2 in NonobeseLoLiRoReNCT01373346
Safety and Efficacy of Long Limb Roux-en Y Reconstruction
A study testing Long limb Roux-en Y reconstruction in people with Diabetes Mellitus Type 2 in Nonobese and Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Nonobese, Gastric Cancer
- What is being tested?
- Long limb Roux-en Y reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed gastric cancer with potentially curable state
- Non-obese (Body mass index: less than 30 kg/m2)
- Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)
- HBA1c: more than 6.5 %, or Fasting glucose: more than 126 mg/dl (7.0mmol/L) or 2-h plasma glucose: more than 200mg/dl during an OGTT or classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose: more than 200mg/dl
- Anti-GAD antibody (-), Anti-islet antibody (-)
- C-peptide level: above 1ng/ml
Who cannot join
- Patient who receive non-curative operation
- Patient who have less than one year life expectancy
- Pregnant patient
- Acute inflammation status patient
- Chronic renal disease patient (Serum creatin level: more than 1.5mg/dl)
- Chronic liver disease patient (Serum AST or ALT level: more than twice of upper limit of normal range)
- Have a history of receiving medications such as dipeptidyl peptidase IV(DPP- IV) inhibitor or glucagon like peptide-I (GLP-I) analogue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial
We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.
Read the detailed description
Type II diabetes in the world is increasing rapidly, and it is known that patients with type II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism.
In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is increased, the number of patients with gastric cancer and T2DM is increased as well.
Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study was a large-series retrospective study including about 400 patients and the result regarding DM improvement was not satisfactory. Based on our previous results, it is needed to find more effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.
- Being tested
- Long limb Roux-en Y reconstruction
- Keywords
- type II diabetes, Gastric cancer, Long limb Roux-en Y
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long limb Roux-en Y reconstructionProcedure or surgery
Also called modified Roux-en Y
After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Long limb Roux-en Y reconstruction | Experimental | Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Receives: Procedure: Long limb Roux-en Y reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.
*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.
For the evaluation of long-term safety, the patients were evaluated every month after discharge.
Measured: Until end of study (on average 14.8 months)
HbA1c
For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Hemoglobin
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Albumin
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Operation Related Mortality
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
Measured: Until end of study (on average 14.8 months)
Secondary outcomes (13)
Matsuda Index
Matsuda Index(Insulin Sensitivity Index) was measured.
The Matsuda index was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI
The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI was obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Measured: Before operation , 6 months after operation , Until end of study (on average 14.8 months)
HOMA-IR
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B
HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
Measured: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)
Matsuda Index : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group.
The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Measured: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI is obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-IR : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group.
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group.
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HbA1c : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group.
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)
The HbA1c was calculated as a ratio to total hemoglobin.
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Hemoglobin : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Albumin : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.
Measured: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 in NonobeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Ho Choi, Gangnam Severance Hospital
- Investigators
- Seung Ho Choi, M.D., Ph.D., Principal investigator, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373346
- Sponsor's protocol ID
- seungho-1
- Acronym
- LoLiRoRe
- Status last verified
- Aug 2012
- First submitted
- 13 Jun 2011
- Last updated
- 3 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
PubMed 19272486Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
PubMed 7677463Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1.
PubMed 17098087FRIEDMAN MN, SANCETTA AJ, MAGOVERN GJ. The amelioration of diabetes mellitus following subtotal gastrectomy. Surg Gynecol Obstet. 1955 Feb;100(2):201-4. No abstract available.
PubMed 13238177ANGERVALL L, DOTEVALL G, TILLANDER H. Amelioration of diabetes mellitus following gastric resection. Acta Med Scand. 1961 Jun;169:743-8. doi: 10.1111/j.0954-6820.1961.tb07885.x. No abstract available.
PubMed 13683582Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.
PubMed 20863527Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.
PubMed 22228970DeFronzo RA, Matsuda M. Reduced time points to calculate the composite index. Diabetes Care. 2010 Jul;33(7):e93. doi: 10.2337/dc10-0646. No abstract available.
PubMed 20587713Emoto M, Nishizawa Y, Maekawa K, Hiura Y, Kanda H, Kawagishi T, Shoji T, Okuno Y, Morii H. Homeostasis model assessment as a clinical index of insulin resistance in type 2 diabetic patients treated with sulfonylureas. Diabetes Care. 1999 May;22(5):818-22. doi: 10.2337/diacare.22.5.818.
PubMed 10332688Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.
PubMed 10902785Frenken M, Cho EY, Karcz WK, Grueneberger J, Kuesters S. Improvement of type 2 diabetes mellitus in obese and non-obese patients after the duodenal switch operation. J Obes. 2011;2011:860169. doi: 10.1155/2011/860169. Epub 2011 Mar 3.
PubMed 21461399Navarrete SA, Leyba JL, Llopis SN. Laparoscopic sleeve gastrectomy with duodenojejunal bypass for the treatment of type 2 diabetes in non-obese patients: technique and preliminary results. Obes Surg. 2011 May;21(5):663-7. doi: 10.1007/s11695-011-0371-8.
PubMed 21336559Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011.
PubMed 16925363DePaula AL, Macedo AL, Mota BR, Schraibman V. Laparoscopic ileal interposition associated to a diverted sleeve gastrectomy is an effective operation for the treatment of type 2 diabetes mellitus patients with BMI 21-29. Surg Endosc. 2009 Jun;23(6):1313-20. doi: 10.1007/s00464-008-0156-x. Epub 2008 Oct 2.
PubMed 18830750Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available.
PubMed 17386401
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01373346
- Acronym / sponsor ID
- LoLiRoRe / seungho-1
- Keywords
- type II diabetes, Gastric cancer, Long limb Roux-en Y
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.
Detailed description
Type II diabetes in the world is increasing rapidly, and it is known that patients with type II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism.
In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is increased, the number of patients with gastric cancer and T2DM is increased as well.
Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study was a large-series retrospective study including about 400 patients and the result regarding DM improvement was not satisfactory. Based on our previous results, it is needed to find more effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long limb Roux-en Y reconstruction | Experimental | Procedure: Long limb Roux-en Y reconstructionLong limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed gastric cancer with potentially curable state
- Non-obese (Body mass index: less than 30 kg/m2)
- Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)
- C-peptide level: above 1ng/ml
Key exclusion criteria (7 listed)
- Patient who receive non-curative operation
- Patient who have less than one year life expectancy
- Pregnant patient
- Acute inflammation status patient
- Chronic renal disease patient (Serum creatin level: more than 1.5mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long limb Roux-en Y reconstructionAlso: modified Roux-en YAfter radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis | Procedure or surgery | Long limb Roux-en Y reconstruction |
Primary outcome
Morbidity
Time frame: Until end of study (on average 14.8 months)
For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. *Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge.
HbA1c
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Hemoglobin
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Albumin
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Operation Related Mortality
Time frame: Until end of study (on average 14.8 months)
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
13 secondary outcomes
Matsuda Index
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI
Time frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months)
HOMA-IR
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index
Time frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)
Matsuda Index : Good Response Group
Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
QUICKI : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-IR : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HOMA-B : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Body Mass Index : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
HbA1c : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Hemoglobin : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Albumin : Good Response Group
Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19272486Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
- Background: PubMed 7677463Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
- Background: PubMed 17098087Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1.
- Background: PubMed 13238177FRIEDMAN MN, SANCETTA AJ, MAGOVERN GJ. The amelioration of diabetes mellitus following subtotal gastrectomy. Surg Gynecol Obstet. 1955 Feb;100(2):201-4. No abstract available.
- Background: PubMed 13683582ANGERVALL L, DOTEVALL G, TILLANDER H. Amelioration of diabetes mellitus following gastric resection. Acta Med Scand. 1961 Jun;169:743-8. doi: 10.1111/j.0954-6820.1961.tb07885.x. No abstract available.
- Background: PubMed 20863527Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.
- Background: PubMed 22228970Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.
- Background: PubMed 20587713DeFronzo RA, Matsuda M. Reduced time points to calculate the composite index. Diabetes Care. 2010 Jul;33(7):e93. doi: 10.2337/dc10-0646. No abstract available.
- Background: PubMed 10332688Emoto M, Nishizawa Y, Maekawa K, Hiura Y, Kanda H, Kawagishi T, Shoji T, Okuno Y, Morii H. Homeostasis model assessment as a clinical index of insulin resistance in type 2 diabetic patients treated with sulfonylureas. Diabetes Care. 1999 May;22(5):818-22. doi: 10.2337/diacare.22.5.818.
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Related trials for Diabetes Mellitus Type 2 in Nonobese
RecruitingPhase 1
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Weight Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Ho Choi, M.D., Ph.D. principal investigator
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long limb Roux-en Y reconstruction in people with Diabetes Mellitus Type 2 in Nonobese and Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: Until end of study (on average 14.8 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373346, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.